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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
510(k) Number K050585
Device Name MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE
Applicant
Dade Behring, Inc.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact ROBERT EUSEBIO
Correspondent
Dade Behring, Inc.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact ROBERT EUSEBIO
Regulation Number866.1640
Classification Product Code
LRG  
Date Received03/07/2005
Decision Date 03/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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